De Novo Powered Air-Purifying Respirator Design and Fabrication for Pandemic Response.
Akshay Kothakonda, Lyla Atta, Deborah Plana, Ferrous Ward, Chris Davis, Avilash Cramer, Robert Moran, Jacob Freake, Enze Tian, Ofer Mazor, Pavel Gorelik, Christopher Van, Christopher Hansen, Helen Yang, Yao Li, Michael S Sinha, Ju Li, Sherry H Yu, Nicole R LeBoeuf, Peter K Sorger
Author Information
Akshay Kothakonda: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Lyla Atta: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Deborah Plana: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Ferrous Ward: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Chris Davis: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Avilash Cramer: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Robert Moran: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Jacob Freake: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Enze Tian: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Ofer Mazor: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Pavel Gorelik: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Christopher Van: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Christopher Hansen: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Helen Yang: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Yao Li: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Michael S Sinha: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Ju Li: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Sherry H Yu: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Nicole R LeBoeuf: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
Peter K Sorger: Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States.
The rapid spread of COVID-19 and disruption of normal supply chains has resulted in severe shortages of personal protective equipment (PPE), particularly devices with few suppliers such as powered air-purifying respirators (PAPRs). A scarcity of information describing design and performance criteria for PAPRs represents a substantial barrier to mitigating shortages. We sought to apply open-source product development (OSPD) to PAPRs to enable alternative sources of supply and further innovation. We describe the design, prototyping, validation, and user testing of locally manufactured, modular, PAPR components, including filter cartridges and blower units, developed by the Greater Boston Pandemic Fabrication Team (PanFab). Two designs, one with a fully custom-made filter and blower unit housing, and the other with commercially available variants (the "Custom" and "Commercial" designs, respectively) were developed; the components in the Custom design are interchangeable with those in Commercial design, although the form factor differs. The engineering performance of the prototypes was measured and safety validated using National Institutes for Occupational Safety and Health (NIOSH)-equivalent tests on apparatus available under pandemic conditions at university laboratories. Feedback was obtained from four individuals; two clinicians working in ambulatory clinical care and two research technical staff for whom PAPR use is standard occupational PPE; these individuals were asked to compare PanFab prototypes to commercial PAPRs from the perspective of usability and suggest areas for improvement. Respondents rated the PanFab Custom PAPR a 4 to 5 on a 5 Likert-scale 1) as compared to current PPE options, 2) for the sense of security with use in a clinical setting, and 3) for comfort compared to standard, commercially available PAPRs. The three other versions of the designs (with a Commercial blower unit, filter, or both) performed favorably, with survey responses consisting of scores ranging from 3 to 5. Engineering testing and clinical feedback demonstrate that the PanFab designs represent favorable alternatives to traditional PAPRs in terms of user comfort, mobility, and sense of security. A nonrestrictive license promotes innovation in respiratory protection for current and future medical emergencies.
